Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Public ClinicalTrials.gov record NCT00625664. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.
Study identification
- NCT ID
- NCT00625664
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 337 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2008 (Type not available)
- Primary completion
- Feb 2011 (Actual)
- Completion
- Feb 2011 (Actual)
- Last update posted
- May 5, 2016
2008 – 2011
United States locations
- U.S. sites
- 52
- U.S. states
- 26
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 840068 | Anchorage | Alaska | 99508 | — |
| Sanofi-Aventis Investigational Site Number 840035 | Berkeley | California | 94704 | — |
| Sanofi-Aventis Investigational Site Number 840012 | Burbank | California | 91505 | — |
| Sanofi-Aventis Investigational Site Number 840029 | La Jolla | California | 92037 | — |
| Sanofi-Aventis Investigational Site Number 840046 | Los Angeles | California | 90033 | — |
| Sanofi-Aventis Investigational Site Number 840003 | Sacramento | California | 95817 | — |
| Sanofi-Aventis Investigational Site Number 840005 | San Bernardino | California | 92404 | — |
| Sanofi-Aventis Investigational Site Number 840033 | San Diego | California | 92103 | — |
| Sanofi-Aventis Investigational Site Number 840031 | Denver | Colorado | 80262 | — |
| Sanofi-Aventis Investigational Site Number 840032 | Stamford | Connecticut | 06902 | — |
| Sanofi-Aventis Investigational Site Number 840034 | Washington D.C. | District of Columbia | 20007 | — |
| Sanofi-Aventis Investigational Site Number 840021 | Washington D.C. | District of Columbia | 20010 | — |
| Sanofi-Aventis Investigational Site Number 840001 | Boca Raton | Florida | 33486 | — |
| Sanofi-Aventis Investigational Site Number 840048 | Boynton Beach | Florida | 33435 | — |
| Sanofi-Aventis Investigational Site Number 840049 | Jacksonville | Florida | 32224 | — |
| Sanofi-Aventis Investigational Site Number 840061 | Lakeland | Florida | 33805 | — |
| Sanofi-Aventis Investigational Site Number 840060 | Athens | Georgia | 30607 | — |
| Sanofi-Aventis Investigational Site Number 840030 | Boise | Idaho | 83712 | — |
| Sanofi-Aventis Investigational Site Number 840024 | Maywood | Illinois | 60153 | — |
| Sanofi-Aventis Investigational Site Number 840062 | Peoria | Illinois | 61615 | — |
| Sanofi-Aventis Investigational Site Number 840039 | Goshen | Indiana | 46526 | — |
| Sanofi-Aventis Investigational Site Number 840054 | Kansas City | Kansas | 66160-7321 | — |
| Sanofi-Aventis Investigational Site Number 840057 | Paducah | Kentucky | 42002 | — |
| Sanofi-Aventis Investigational Site Number 840004 | Metarie | Louisiana | 70006-290 | — |
| Sanofi-Aventis Investigational Site Number 840045 | Baltimore | Maryland | 21201 | — |
| Sanofi-Aventis Investigational Site Number 840006 | Detroit | Michigan | 48201 | — |
| Sanofi-Aventis Investigational Site Number 840026 | Lansing | Michigan | 48510 | — |
| Sanofi-Aventis Investigational Site Number 840047 | Saint Joseph | Michigan | 49805 | — |
| Sanofi-Aventis Investigational Site Number 840009 | Hackensack | New Jersey | 07601 | — |
| Sanofi-Aventis Investigational Site Number 840044 | Lake Success | New York | 11042 | — |
| Sanofi-Aventis Investigational Site Number 840013 | New York | New York | 10021 | — |
| Sanofi-Aventis Investigational Site Number 840050 | New York | New York | 10032 | — |
| Sanofi-Aventis Investigational Site Number 840056 | Rochester | New York | 14642 | — |
| Sanofi-Aventis Investigational Site Number 840015 | Syracuse | New York | 13210 | — |
| Sanofi-Aventis Investigational Site Number 840041 | Chapel Hill | North Carolina | 27599 | — |
| Sanofi-Aventis Investigational Site Number 840007 | Charlotte | North Carolina | 28204 | — |
| Sanofi-Aventis Investigational Site Number 840019 | Sylvania | Ohio | 43560 | — |
| Sanofi-Aventis Investigational Site Number 840020 | Bethlehem | Pennsylvania | 18015 | — |
| Sanofi-Aventis Investigational Site Number 840065 | Dunmore | Pennsylvania | 18512 | — |
| Sanofi-Aventis Investigational Site Number 840058 | Woonsocket | Rhode Island | 02895 | — |
| Sanofi-Aventis Investigational Site Number 840052 | Charleston | South Carolina | 29406 | — |
| Sanofi-Aventis Investigational Site Number 840002 | Knoxville | Tennessee | 37920 | — |
| Sanofi-Aventis Investigational Site Number 840008 | Houston | Texas | 77014 | — |
| Sanofi-Aventis Investigational Site Number 840018 | Houston | Texas | 77030 | — |
| Sanofi-Aventis Investigational Site Number 840017 | Lubbock | Texas | 79415 | — |
| Sanofi-Aventis Investigational Site Number 840016 | San Antonio | Texas | 78229 | — |
| Sanofi-Aventis Investigational Site Number 840064 | Temple | Texas | 76508 | — |
| Sanofi-Aventis Investigational Site Number 840010 | The Woodlands | Texas | 77380 | — |
| Sanofi-Aventis Investigational Site Number 840036 | Seattle | Washington | 98111 | — |
| Sanofi-Aventis Investigational Site Number 840011 | Madison | Wisconsin | 53792 | — |
| Sanofi-Aventis Investigational Site Number 840025 | Marshfield | Wisconsin | 54449 | — |
| Sanofi-Aventis Investigational Site Number 840038 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 108 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00625664, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2016 · Synced Oct 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00625664 live on ClinicalTrials.gov.